Medicare Final Rules 2022

What Can You Do to Protect Patients and Avoid Disruptions in Care?

Urge Your Member of Congress to Pass Medicare Fixes

To combat these immediate threats to Medicare, contact your Member of Congress today and urge them to cosponsor the bipartisan "Supporting Medicare Providers Act of 2022" (H.R. 8800), introduced by Representatives Ami Bera, MD (D-CA) and Larry Bucshon, MD (R-IN), that will prevent the scheduled 4.5% Medicare payment reduction from going into effect in January 2023 and a second bipartisan bill, H.R. 6048, the "Medicare Stability for Patients and Providers Act" (H.R. 6048), introduced by Representatives Bobby Rush (D-IL) and Gus Bilirakis (R-FL), that would correct the implementation of Medicare’s clinical labor formula.

Members of Congress value these contacts and consider the number of individual constituents that take the time to reach out to their offices on matters of legislative importance. SCAI is engaged in a number of activities including working in coalition with several like-minded physician and healthcare provider groups as well as making individual contact with Members of Congress, their staff, committees of jurisdiction, and the White House.

What is SCAI doing?

SCAI’s government relations team is in constant contact with policymakers on Capitol Hill, CMS, and the White House and works collaboratively in coalition with several physician and healthcare provider groups that championed the following:

If you have questions, please contact Curtis Rooney, Vice President, Government Relations, or Rachel Weston, Senior Associate, Government Relations.

SCAI will continue to fight these damaging Medicare cuts and update members of SCAI on an ongoing basis.

In general, physicians and other health professionals are paid under Medicare Part B for services that include office visits, surgical procedures, and other diagnostic and therapeutic efforts. To determine payment, Medicare uses a physician fee schedule that is based on the relative resources typically used to furnish the service. These RVUs are applied to each service for physician work, practice expense, and malpractice. CMS multiplies these RVUs by a “conversion factor” to determine the Medicare payment amounts for each physician service. The following chart describes the interventional cardiology codes for angioplasty and revascularization that will be reduced on January 1, 2022. A spreadsheet that describes specific reductions in payments for angioplasty and revascularization is provided here.

CMS Adds Additional Rules for Evaluation and Management (E/M) Billing

As part of its ongoing review of payments for E/M visit code sets, CMS finalized its proposed refinements and updates to coding and payment for evaluation and management (E/M) visits. Specifically, CMS is clarifying their policies on billing for split (or shared) visits to reflect changes in the recent E/M visit coding and payment, the current practice of medicine, and the evolving role of nonphysician practitioners (NPPs) as members of the medical team.

As background, previously a split (or shared) visit referred to an E/M visit that is performed (“split” or “shared”) by both a physician and a NPP who are in the same group. In the CY 2022 PFS final rule, CMS makes the following changes to split (or shared) E/M visits:

Redefining a split (or shared) E/M visit as a visit in the facility that is performed by both a physician and an NPP who are in the same group
For 2023, finalizing the definition of a substantive portion of visit as more than half of the total time spent and, for 2022, defining the list of activities included in the substantive portion as history, physical exam, medical decision-making(except for critical care, which can only be more than half of the total time)
Clarifying that the practitioner who provides the “substantive portion” of the visit (now defined as more than half of the total time spent performing the visit) would bill for the visit
Allowing for split (or shared) visits to be reported for new as well as established patients, initial and subsequent visits, and prolonged services
Requiring reporting of a modifier on the claim to describe split (or shared) visits for program integrity and quality considerations
Requiring documentation in the medical record of the two individuals who performed the visit and a signature and date for the individual providing the substantive portion

CMS also provided additional clarification on teaching physician visits and determining the office/outpatient E/M visit level. CMS clarified that only the time that the teaching physician was present for qualifying activities, for example, can be included. In addition, under the primary care exception, only medical decision-making (MDM), not time, can be used to select office/outpatient E/M visit level. Currently, under the primary care exception, Medicare makes PFS payments in certain teaching hospital primary care centers for certain services of lower and midlevel complexity furnished by a resident without the physical presence of a teaching physician.

Medicare Preserves Telehealth Services Until End of 2023

CMS will not yet permanently add any of the services that were temporarily added to the Medicare telehealth services list during the COVID-19 Public Health Emergency (PHE). However, all services added to Category 3 criteria will remain until the end of CY 2023, which will allow enough time to consider adding these services permanently. Last year, CMS created the new Category 3 to capture Medicare telehealth services that are permitted on a temporary basis during the PHE. The lack of permanently added telehealth flexibilities is certainly disappointing to stakeholders who have been advocating for the waivers adopted during the PHE to remain. However, Congress must first pass a law to remove geographical and originating site limitations for telehealth services used by all Medicare beneficiaries.

CMS Updates Quality Payment Program, Targets 2023 for MIPS Value Pathway Implementation

CMS finalized proposals for the Quality Payment Program (QPP), which includes two tracks:

The Merit-based Incentive Payment System (MIPS)
Advanced Alternative Payment Models (APMs)

MIPS-eligible clinicians, including interventional cardiologists, receive a payment adjustment based on their performance in four categories:

Quality
Cost
Improvement activities
Promoting interoperability

The upcoming 2022 performance year will impact payment in 2024. For MIPS, the statute specifies the weight of each category in CY 2022 as follows:

Quality: 30 percent
Cost: 30 percent
Improvement activities: 15 percent
Promoting interoperability: 25 percent

These category weights mean an increase of 10 percent for the cost category and a decrease of 10 percent for the quality category. Five new cost measures are now included in this category.

Clinicians participating in an eligible Advanced APM are excluded from MIPS reporting requirements and payment adjustment. In CY 2020 rulemaking, CMS finalized the creation of the MIPS Value Pathways (MVPs), a reporting option for MIPS that the agency believes will provide a more cohesive participation experience by aligning activities from the four MIPS performance categories around a certain specialty, medical condition, or patient population. CMS originally intended to begin the transition to the MVPs in 2021 but delayed the transition due to the COVID-19 pandemic. CMS has now finalized plans to move forward with a gradual transition beginning in the 2023 MIPS performance year/CY 2025 payment year; with voluntary participation in this initial year. Seven MVPs will be available in the 2023 performance year.

MVP participants will be able to select and report on four quality measures, including one outcome measure and one high-priority measure. For improvement activities, participants must report one of the following: two medium-weighted activities, one high-weighted activity, or participate in a patient-centered medical home (PCMH) or comparable specialty practice. Cost measures are also to be included in the MVP. CMS plans to gradually implement MVPs for all specialties and subspecialties.

CMS will allow MIPS-eligible clinicians to report the APM Performance Pathway (APP) beginning in the 2023 performance year. To address Accountable Care Organizations’ (ACOs’) concerns regarding the transition to eCQMs /MIPS CQMs, which require the submission of all-payer quality data, CMS finalized a longer transition for Shared Savings Programs ACOs by extending the CMS Web Interface as a reporting option for three years through PY2024. ACOs will be required to report the three eCQMs/MIPS CQMs beginning in PY2025. These finalized policies will provide four years for ACOs to transition to reporting the three eCQMs/MIPS CQMs under APP and to meet the increased Shared Savings Program quality performance standard.

Self-Referral Regulation Continues to Capture Attention of CMS

Under this final regulation, CMS will consider any payment to the physician, or the physician's family, for anything other than the services the physician personally performs, an indirect compensation arrangement. Further, CMS will consider the fair market value of a service; variables related to quantity or value of a referral, and other business the physician may generate for an entity when evaluating the indirect compensation arrangement.

CMS Defines ‘Unit’ for Determination of Indirect Compensation Arrangements

Since finalizing the Modernizing and Clarifying the Physician Self-Referral Regulations (MCR rule) in late 2020, CMS has received inquiries on the definition of "unit". To facilitate compliance with the physician self-referral law, with this regulation, CMS finalizes its definition of an individual unit as:

Time, where the compensation paid to the physician is based solely on the period of time during which the services are provided;
Service, where the compensation paid to the physician is based solely on the service provided; and/or
Time, where the compensation paid to the physician is a hybrid of the time period of the service and the service itself.

Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems

On November 2, 2021, CMS posted a press release, fact sheet, and a display version (see links below) of its final rule with comment period, related to Hospital OPPS and ASC payment systems and quality reporting programs, which finalizes updates for CY 2022 payment systems and includes other specific proposals:

Apply payment update of 2.0 percent for CY 2022
Halt the elimination of the Inpatient Only (IPO) list and add 292 services to the list
Exempt procedures that are removed from the IPO list from medical reviews for 2 years
Reverse the expansion of the Ambulatory Surgical Center Covered Procedures List (ASC-CPL)
Amend hospital price transparency policies to increase penalties and encourage compliance
Update measures and refine the requirements for quality reporting programs
Continue current 340B policy of paying an adjusted amount of ASP minus 22.5 percent
Continue separate payment for certain non-opioid pain management drugs in ASCs, and
Revise the radiation oncology (RO) model and include a new start date of January 1, 2022

Because of COVID-19, CMS uses CY 2019 data instead of CY 2020 data for setting CY 2022 payment rates. The final rule was published in the Federal Register on November 16, 2021, and comments are due within 30 days of publication. Provisions of the final rule with comment are effective January 1, 2022.

Outpatient and ASC Rates Increase by 2.0 Percent

CMS finalized a 2.0 percent increase to the OPPS CY 2021 conversion factor, which is based on a market basket increase of 2.7 percent and reduced by a productivity adjustment of 0.7 percentage points. After accounting for expected changes in enrollment, utilization, and case mix, CMS estimates these proposals will result in an estimated $82.1 billion in payments ($5.9 billion more than estimated CY 2022 payments). CMS also finalized a 2.0 percent increase to the ASC CY 2021 conversion factor, which continues its policy to update ASC payments using the hospital market basket update. This will result in an estimated $5.41 billion in ASC payments for CY 2022 ($40 million more than estimated CY 2021 payments). CMS restates its support for site neutrality and states that this policy is expected to last through CY 2023.

CMS Continues Use of PFS-Equivalent for Clinic Visits at OPDs

CMS will continue the policy it adopted in 2019 to reduce OPPS payments for clinic visits when provided at an off-campus provider-based department (PBD) and reimbursed under OPPS. In 2020, CMS completed the phase-in, which reduced payments for these services to a physician fee schedule equivalent of 40 percent of the OPPS rate. CMS believes that these services may be overutilized as they are the most common service billed under OPPS and typically occur in a physician's office.

Reversal of Decision to Eliminate the Inpatient Only (IPO) List

CMS established the IPO list in 2000 to designate procedures that, because of their invasive nature, expected recovery time, and/or underlying patient condition, would not be paid if performed in an outpatient facility. The Agency believed that performing certain procedures on an outpatient basis would not be safe or appropriate, and therefore not reasonable and necessary under Medicare rules.

For CY 2021, CMS reversed this longstanding policy and decided to eliminate the IPO list over three years. However, based on a clinical review by its internal physicians, CMS now believes that this decision may not adequately protect Medicare beneficiaries. In this rule for CY 2022, CMS finalizes its proposal with modification to pause the elimination of the IPO list and add 291 previously removed services and 1 new service to the IPO list. The new service is:

CPT code 0643T (Transcatheter left ventricular restoration device implantation including right and left heart catheterization and left ventriculography when performed, arterial approach). Of the 298 services that were originally removed, seven will not be added back to the IPO list.

CMS also finalized their proposal to amend the regulation at 42 CFR 419.22(n) to remove the reference to the elimination of the list of services and procedures designated as requiring inpatient care (through G0463 – Hospital outpatient clinic visit for assessment and management of a patient). In September 2019, a federal district court sided with hospital plaintiffs, ruling that CMS lacked statutory authority to implement the change. But, in July 2020, the US Court of Appeals for the District of Columbia Circuit ruled in favor of CMS, holding that the agency’s regulation was a reasonable interpretation of statutory authority. In June 2021, the Supreme Court declined to consider the decision. See, 63 FR 47571 8 85 FR 86084 through 86088 Page 3 of 11. This portion of the rule includes a 3-year transition and codifies their five longstanding criteria for determining whether a service or procedure should be removed from the IPO list in the regulation. See, new 42 CFR 419.23.

Exemption of Procedures Removed from the IPO List from Medical Review

Historically, items on the IPO list were an exception to the “2-midnight rule” and considered appropriate for inpatient hospital admission and payment, regardless of length of stay. In CY 2021, CMS finalized a policy to exempt procedures removed from the IPO list from certain medical review activity until such procedures are commonly billed in the outpatient setting. In this rule for CY 2022, CMS finalizes a specific timeframe of 2 years for this exemption.

Reversal of Decision to Expand ASC-Covered Procedures List (ASC-CPL)

The ASC-CPL includes covered surgical procedures eligible for Medicare payment when performed in an ASC. Procedures on the ASC-CPL are not expected to pose a significant patient risk and do not typically require active medical monitoring and care at midnight following the procedure. For CY 2021, CMS revised its policy for adding procedures to the ASP-CPL and made 267 surgery codes eligible for the CPL based on clinician discretion. Similar to the IPO list, CMS now reinstates its prior policy and removes several of the recently-added procedures from the list. After reviewing comments, CMS determined that a total of six procedures should either remain on or be added to the CPL. CMS also finalized their proposal to adopt a nomination process, under which stakeholders may nominate procedures to be added to the ASC CPL. CMS will provide sub-regulatory guidance on the nomination process in early 2022, with procedure nominations due in March 2022, and the formal nomination process beginning in CY 2023.

Devices and Diagnostics CMS

CMS proposes to Define Procedures with Device-Intensive Status in ASCs For CY 2022. CMS finalized their proposal to assign a device offset percentage based on CY 2020 data, if CY 2020 claims information is available, for procedures that were assigned device-intensive status (but because CY 2019 claims data is not available). CMS states that it would otherwise assign a default device offset percentage of 31 percent, or a device offset percentage based on claims from a clinically-similar code. Based on updated data for this CY 2022 OPPS/ASC final rule with comment period, CMS applies the device offset percentages from 2020 claims data to more than a dozen procedures, including:

C9765 (Revascularization, endovascular, open or percutaneous, lower extremity artery(ies), except tibial/peroneal; with intravascular lithotripsy, and transluminal stent placement(s), includes angioplasty within the same vessel(s), when performed); and
C9767 (Revascularization, endovascular, open or percutaneous, lower extremity artery(ies), except tibial/peroneal; with intravascular lithotripsy and transluminal stent placement(s), and atherectomy, includes angioplasty within the same vessel(s), when performed).

CMS Approves Three Devices for Pass-Through Payments Beginning in CY2022

Eight applications for device pass-through payments were submitted for CY 2022. CMS sought comments on each application and approved three out of the eight devices for passthrough payments. The two devices with FDA Breakthrough Device designation and marketing authorization are RECELL® and Shockwave C2 Coronary Intravascular Lithotripsy Catheter, applied under the alternative pathway for pass-through status. Under this alternate pathway, these products are not evaluated for substantial clinical improvement but must meet all other pass-through requirements.

The other six applications were evaluated through the traditional pass-through pathway include:

RECELL® System AVITA Medical —Approved
Shockwave C2 Coronary IVL Catheter Shockwave Medical — Approved
AngelMed Guardian® System Angel Medical Systems —Approved
BONEBRIDGE Bone Conduction Implant System MED-EL Corporation —Not Approved. Does not meet substantial clinical improvement criterion.
EluviaTM Drug-Eluting Vascular Stent System Boston Scientific Corporation —Not Approved. Does not meet the cost criterion.
Cochlear™ Osia® 2 System Cochlear Americas —Not Approved. Does not meet substantial clinical improvement criterion.
Pure-Vu® System Motus GI —Not Approved. Does not meet substantial clinical improvement criterion.
Xenoscope™ Xenocor Inc. —Not Approved. Does not meet substantial clinical improvement criterion.

Currently, 11 device categories are eligible for pass-through payment. Similar to the policy adopted for certain pass-through drugs and biologicals, CMS will extend the pass-through status of C1823 for four quarters to collect the necessary claims data to set CY 2023 payment rates. Thus, passthrough status will expire on December 31, 2021, for one device, on December 31, 2022, for five devices, on December 31, 2023, for four devices, and on December 31, 2024, for one device. C1761-Catheter, transluminal intravascular lithotripsy coronary. Effective 7.01/2021-06.30.2024.

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